A Phase 3 interventional study of Rituxan and CT-P10 in Lymphoma, Follicular, sponsored by Celltrion. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-29.
Sponsored by Celltrion · Phase 3, Interventional, and Treatment
This study is a Phase 3 prospective, randomised, parallel-group, active controlled, double blind, multicentre, international study with 2 coprimary endpoints designed to demonstrate equivalence in pharmacokinetics (Part 1), as well as noninferiority in efficacy (Part 2), of CT-P10 to Rituxan when coadministered with CVP and to assess efficacy and safety in patients with advanced (stage III-IV) FL. Part 1 and Part 2 of the study will run in parallel.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 140 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Celltrion is the lead sponsor of 76 studies on the registry; 3 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 13 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient has at least 1 measurable tumour mass that has not previously been irradiated, and the mass must be:
Exclusion Criteria:
Patient has received previous treatment for NHL:
Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.
Biological: CT-P10 · Drug: Cyclophosphamide · Drug: Vincristine · Drug: Prednisone
Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 \[max 2 mg\] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period. Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.
Biological: Rituxan · Drug: Cyclophosphamide · Drug: Vincristine · Drug: Prednisone
Also known as: Rituximab
Also known as: Rituximab
Also known as: Prednisolone
Area Under the Serum Concentration-time Curve at Steady State (AUCtau)
AUCtau: Area under the plasma drug concentration-time curve within a dosing interval at steady state. PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained.
Time frame: Core Cycle 4 (Week 12)
Maximum Serum Concentration at Steady State (Cmax,ss)
Cmax,ss: Maximum concentration of drug in plasma at steady state on administering a fixed dose at equal dosing intervals. PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained.
Time frame: Core Cycle 4 (Week 12)
Overall Response Rate (ORR) According to the 1999 International Working Group (IWG) Criteria
ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR) by central review. Per 1999 IWG criteria, the disease status was assessed by using contrasted CT, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: \>=75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: \>=50% decrease in SPD of target lesions and no evidence of disease progression.
Time frame: During the Core Study Period (up to 8 cycles; Week 24)
B-cell Kinetics (B-cell Depletion and Recovery)
B-cell kinetics were demonstrated by median values of B-cell counts (Lower limit of quantification was 20 cells/uL).
Time frame: Cycles 1 to 8 during the Core Study Period
| Milestone | CT-P10 | Rituxan |
|---|---|---|
| Started | 70 | 70 |
| Completed | 62 | 62 |
| Not completed | 8 | 8 |
| Withdrew: Progressive disease | 2 | 3 |
| Withdrew: Adverse event | 4 | 1 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Death | 1 | 0 |
| Milestone | CT-P10 | Rituxan |
|---|---|---|
| Started | 62 | 60 |
| Completed | 46 | 38 |
| Not completed | 16 | 22 |
| Withdrew: Progressive disease | 11 | 13 |
| Withdrew: Adverse event | 3 | 3 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Withdrawal by subject | 0 | 3 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Stable disease | 0 | 1 |
AUCtau: Area under the plasma drug concentration-time curve within a dosing interval at steady state. PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained.
| h*ug/mL | CT-P10 | Rituxan |
|---|---|---|
| Area Under the Serum Concentration-time Curve at Steady State (AUCtau) | 41002.43 ± 1.136 | 40099.08 ± 1.143 |
Cmax,ss: Maximum concentration of drug in plasma at steady state on administering a fixed dose at equal dosing intervals. PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained.
| ug/mL | CT-P10 | Rituxan |
|---|---|---|
| Maximum Serum Concentration at Steady State (Cmax,ss) | 256.19 ± 1.115 | 254.49 ± 1.120 |
ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR) by central review. Per 1999 IWG criteria, the disease status was assessed by using contrasted CT, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: \>=75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: \>=50% decrease in SPD of target lesions and no evidence of disease progression.
| Participants | CT-P10 | Rituxan |
|---|---|---|
| Overall Response Rate (ORR) According to the 1999 International Working Group (IWG) Criteria | 64 | 63 |
B-cell kinetics were demonstrated by median values of B-cell counts (Lower limit of quantification was 20 cells/uL).
| cells/uL | CT-P10 | Rituxan |
|---|---|---|
| Core Cycle 1 (Predose) | 92.5 (20 to 2890) | 62.0 (20 to 2890) |
| Core Cycle 1 (1 hour after the end of infusion) | 20.0 (20 to 1108) | 20.0 (20 to 51) |
| Core Cycle 2 (Predose) | 20.0 (20 to 1750) | 20.0 (20 to 2890) |
| Core Cycle 3 (Predose) | 20.0 (20 to 231) | 20.0 (20 to 35) |
| Core Cycle 4 (Predose) | 20.0 (20 to 51) | 20.0 (20 to 20) |
| Core Cycle 5 (Predose) | 20.0 (20 to 20) | 20.0 (20 to 20) |
| Core Cycle 6 (Predose) | 20.0 (20 to 33) | 20.0 (20 to 20) |
| Core Cycle 7 (Predose) | 20.0 (20 to 24) | 20.0 (20 to 20) |
| Core Cycle 8 (Predose) | 20.0 (20 to 20) | 20.0 (20 to 20) |
Collected over Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CT-P10 | — | 24/70 (34.3%) | 58/70 (82.9%) |
| Rituxan | — | 13/70 (18.6%) | 57/70 (81.4%) |
| Event | CT-P10 | Rituxan |
|---|---|---|
| PneumoniaInfections and infestations | 4/70 | 1/70 |
| Febrile neutropeniaBlood and lymphatic system disorders | 2/70 | 3/70 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 2/70 | 1/70 |
| Lower respiratory tract infectionInfections and infestations | 1/70 | 2/70 |
| Upper respiratory tract infectionInfections and infestations | 0/70 | 2/70 |
| Deep vein thrombosisVascular disorders | 1/70 | 0/70 |
| HypertensionVascular disorders | 1/70 | 0/70 |
| Peripheral ischaemiaVascular disorders | 0/70 | 1/70 |
| ThrombophlebitisVascular disorders | 0/70 | 1/70 |
| Adenocarcinoma gastricNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/70 | 0/70 |
| Event | CT-P10 | Rituxan |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 27/70 | 20/70 |
| Infusion related reactionInjury, poisoning and procedural complications | 16/70 | 19/70 |
| Upper respiratory tract infectionInfections and infestations | 14/70 | 18/70 |
| Neuropathy peripheralNervous system disorders | 10/70 | 12/70 |
| ConstipationGastrointestinal disorders | 12/70 | 10/70 |
| Back painMusculoskeletal and connective tissue disorders | 2/70 | 12/70 |
| Abdominal painGastrointestinal disorders | 8/70 | 11/70 |
| AlopeciaSkin and subcutaneous tissue disorders | 10/70 | 5/70 |
| NauseaGastrointestinal disorders | 9/70 | 7/70 |
| ParaesthesiaNervous system disorders | 3/70 | 8/70 |
All randomized patients (ITT population)
| Age, Continuous(years) | CT-P10 | Rituxan | Total |
|---|---|---|---|
| Median | 57.0 (30 to 85) | 58.5 (26 to 84) | 57.5 (26 to 85) |
| Sex: Female, Male(Participants) | CT-P10 | Rituxan | Total |
|---|---|---|---|
| Female | 40 | 37 | 77 |
| Male | 30 | 33 | 63 |
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